NovoFine® Plus 32G 185550Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00301691855505), received between Jan 2, 2019 and Jul 24, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Break” (3 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJul 24, 2025Break; Break

  EVENT VERBATIM [PREFERRED TERM] (RELATED SYMPTOMS IF ANY SEPARATED BY COMMAS). NEEDLE WAS IN SKIN AND, AFTER A WEEK THE NEEDLE WORKED ITS WAY OUT [INJURY ASSOCIATED WITH DEVICE]. NEEDLES KEEP BREAKING AND BENDING [NEEDLE ISSUE]. CASE DESCRIPTION: THIS SERIOUS SPONTANEOUS CASE FROM THE UNITED STATES WAS REPORTED BY A CONSUMER AS "NEEDLE WAS IN SKIN AND, AFTER A WEEK THE NEEDLE WORKED ITS WAY OUT(INJURY ASSOCIATED WITH DEVICE)" WITH AN UNSPECIFIED ONSET DATE, "NEEDLES KEEP BREAKING AND BENDING(NEEDLE BROKEN)" WITH AN UNSPECIFIED ONSET DATE, AND CONCERNED A FEMALE PATIENT WHO WAS TREATED WITH NOVOFINE PLUS 4MM (32G) (NEEDLE) FROM UNKNOWN START DATE FOR "TYPE 2 DIABETES MELLITUS", CURRENT CONDITION: TYPE 2 DIABETES MELLITUS (DURATION NOT REPORTED). CONCOMITANT MEDICATIONS INCLUDED - OZEMPIC 0.25/0.50 MG (SEMAGLUTIDE 1.34 MG/ML) SOLUTION FOR INJECTION. ON AN UNKNOWN DATE PATIENT REPORTED NEEDLE WAS IN SKIN AND DID NOT KNOW ABOUT IT FOR A WEEK OR SO TO WORK ITS WAY OUT. IT WAS SCARY TO THE PATIENT. ADDITIONALLY, PATIENT REPORTED NEEDLES KEPT BREAKING AND BENDING, PATIENT HAS TO DISCARD IT. BATCH NUMBERS NOVOFINE PLUS 4MM (32G) WAS REQUESTED. ACTION TAKEN TO NOVOFINE PLUS 4MM (32G) WAS NO

  Patient problems: Needle Stick/Puncture

  MAUDE report 22585542 ↗
• InjuryJun 21, 2021Break; Break

  EVENT VERBATIM [PREFERRED TERM] (RELATED SYMPTOMS IF ANY SEPARATED BY COMMAS). NEEDLE BROKE INSIDE SKIN AT INJECTION SITE [NEEDLE ISSUE]. NEEDLE BROKE INSIDE SKIN AT INJECTION SITE [INJECTION SITE INJURY]. NEEDLE BROKE INSIDE SKIN AT INJECTION SITE [INJURY ASSOCIATED WITH DEVICE]. THIS SERIOUS SPONTANEOUS CASE FROM THE UNITED STATES WAS REPORTED BY A CONSUMER AS "NEEDLE BROKE INSIDE SKIN AT INJECTION SITE(NEEDLE BROKEN)" WITH AN UNSPECIFIED ONSET DATE, "NEEDLE BROKE INSIDE SKIN AT INJECTION SITE(INJECTION SITE INJURY)" WITH AN UNSPECIFIED ONSET DATE, "NEEDLE BROKE INSIDE SKIN AT INJECTION SITE(NEEDLE STICK/PUNCTURE)" WITH AN UNSPECIFIED ONSET DATE, AND CONCERNED A ADULT FEMALE PATIENT (BORN IN 1951) WHO WAS TREATED WITH NOVOFINE PLUS 4MM (32G) (NEEDLE) FROM UNKNOWN START DATE FOR "DEVICE THERAPY". MEDICAL HISTORY WAS NOT PROVIDED. ON AN UNSPECIFIED DATE, THE PATIENT REPORTED THAT THE NEEDLE BROKE AT INJECTION SITE AND WAS STILL STUCK IN SKIN. BATCH NUMBERS: NOVOFINE PLUS 4MM (32G): 20F13N. ACTION TAKEN TO NOVOFINE PLUS 4MM (32G) (NEEDLE) WAS NOT REPORTED. THE OUTCOME FOR THE EVENT "NEEDLE BROKE INSIDE SKIN AT INJECTION SITE(NEEDLE BROKEN)" WAS RECOVERED. THE OUTCOME FOR THE EVENT "

  Patient problems: Administration Site Reaction; Device Embedded In Tissue or Plaque

  MAUDE report 12030775 ↗
• InjuryJan 22, 2021Break; Material Twisted/Bent; Break; Material Twisted/Bent

  CASE DESCRIPTION: THIS SERIOUS SPONTANEOUS CASE FROM THE UNITED STATES WAS REPORTED BY A CONSUMER AS "BENT NEEDLE BROKE OFF IN SKIN(NEEDLE INJURY)" WITH AN UNSPECIFIED ONSET DATE, "BENT NEEDLE BROKE OFF IN SKIN(NEEDLE BROKEN)" WITH AN UNSPECIFIED ONSET DATE, "NEEDLES WERE BENT(NEEDLE BENT)" WITH AN UNSPECIFIED ONSET DATE, AND CONCERNED A 70 YEARS OLD FEMALE PATIENT WHO WAS TREATED WITH NOVOFINE PLUS 4MM (32G) (NEEDLE) FROM UNKNOWN START DATE FOR "DEVICE THERAPY", , NOVOFINE PLUS 4MM (32G) (NEEDLE) FROM UNKNOWN START DATE FOR "DEVICE THERAPY", , OZEMPIC 0.25/0.50 MG (SEMAGLUTIDE) FROM UNKNOWN START DATE FOR "DRUG USE FOR UNKNOWN INDICATION". ON AN UNSPECIFIED DATE, THE PATIENT REPORTED THAT IN EACH BOX OF THE OZEMPIC PEN THERE WERE NOVOFINE PLUS 32G 4MM NEEDLES THAT WERE BENT AND DID NOT ALLOW THE PATIENT TO USE A NEW NEEDLE EACH TIME. THE PATIENT ADDITIONALLY REPORTED THAT ONE OF THE BENT NEEDLES BROKE OFF IN THEIR SKIN AND HAD TO REMOVED USING TWEEZERS. BATCH NUMBERS: NOVOFINE PLUS 4MM (32G): 20B14N, NOVOFINE PLUS 4MM (32G): REQUESTED, OZEMPIC 0.25/0.50 MG: KP52286. INVESTIGATION RESULTS: PRODUCT NAME: NOVOFINE PLUS 32G X 4MM BATCH NUMBER: 20B14N. MICROSCOPIC EXAMINATION PERFORMED

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 11216474 ↗
• InjuryOct 20, 2020Nonstandard Device; Nonstandard Device

  CASE DESCRIPTION: INVESTIGATIONAL RESULTS: NOVOFINE® PLUS 32G X 4MM (BATCH NUMBER: 20C04N). MICROSCOPIC EXAMINATION PERFORMED. NEEDLE POINTS ON PATIENT NEEDLES EXAMINED VISUALLY FOR DEFECTS. NEEDLES TESTED FOR SILICONE ON PATIENT NEEDLE. THE PRODUCT WAS FOUND TO BE NORMAL. THE RESULTS WERE FOUND TO COMPLY WITH SPECIFICATIONS. DURING TEST IT HAS NOT BEEN POSSIBLE TO DETECT ANY IRREGULARITIES RELATED TO THE COMPLAINT ON THE UNUSED NEEDLES. SINCE LAST SUBMISSION, THE CASE HAS BEEN UPDATED WITH THE FOLLOWING: -INVESTIGATIONAL RESULTS FOR NOVOFINE NEEDLE UPDATED; -IMDRF CODES ANNEX B, C AND D UPDATED; -NARRATIVE UPDATED ACCORDINGLY. FINAL MANUFACTURER'S COMMENT: 24-NOV-2020: SINCE NO FAULTS WERE FOUND ON THE RETURNED DEVICE NOVOFINE PLUS NEEDLES (BATCH NO. 20C04N) AND ONLY VERY LIMITED INFORMATION REGARDING THE PATIENTS HANDLING OF THE SUSPECTED DEVICE IS REPORTED IN THE CASE, IT IS NOT POSSIBLE TO ELUCIDATE A CLEAR ROOT CAUSE FOR THE EXPERIENCED ADVERSE EVENT. INJECTION SITE PAIN IS POSSIBLE WITH NOVOFINE PLUS NEEDLE AS PAIN IS SUBJECTIVE. IT COULD BE RELATED TO INCORRECT HANDLING OF THE PRODUCT. H3 CONTINUED: EVALUATION SUMMARY; NOVOFINE® PLUS 32G X 4MM : BATCH 20C04N; MICROSCOPIC EXA

  Patient problems: Administration Site Reaction

  MAUDE report 10706987 ↗
• InjuryJan 2, 2019No Flow; No Flow

  EVENT VERBATIM [PREFERRED TERM] (RELATED SYMPTOMS IF ANY SEPARATED BY COMMAS); HIGH BLOOD SUGARS OF 500MG/DL [BLOOD GLUCOSE INCREASED]; NEEDLE IS BENDING WHEN HE INJECTS HIMSELF [NEEDLE ISSUE]; NEEDLE WAS CLOGGING UP [NEEDLE ISSUE]; NOT GETTING HIS INSULIN [DEVICE FAILURE]. CASE DESCRIPTION: THIS SERIOUS SPONTANEOUS CASE FROM THE UNITED STATES WAS REPORTED BY A CONSUMER AS "HIGH BLOOD SUGARS OF 500MG/DL" BEGINNING ON (B)(6) 2018, "NEEDLE IS BENDING WHEN HE INJECTS HIMSELF" BEGINNING ON (B)(6) 2018, "NEEDLE WAS CLOGGING UP" BEGINNING ON (B)(6) 2018, "NOT GETTING HIS INSULIN" BEGINNING ON (B)(6) 2018, AND CONCERNED A (B)(6) YEARS OLD MALE PATIENT WHO WAS TREATED WITH NOVOFINE PLUS 4MM (32G) (NEEDLE) FROM (B)(6) 2018 AND ONGOING DUE TO "TYPE 2 DIABETES MELLITUS". PATIENT HEIGHT, WEIGHT AND BODY MASS INDEX WAS NOT REPORTED. MEDICAL HISTORY INCLUDED TYPE 2 DIABETES MELLITUS, CANCER, AND DIABETIC NEUROPATHY. IT WAS REPORTED THAT PATIENT WAS USING 30 GAUGE NEEDLES (UNSPECIFIED) WHICH WERE DISCONTINUED ON AN UNKNOWN DATE. ON (B)(6) 2018, THE NEEDLE WAS BENDING OR CLOGGING UP AND NOT LETTING INSULIN GET THROUGH THE PATIENT'S SKIN. THE PATIENT HAD BLOOD GLUCOSE OF 500MG/DL, DUE TO NOT GETTIN

  Patient problems: Hyperglycemia

  MAUDE report 8211179 ↗